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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR

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ABBOTT VASCULAR MITRACLIP SYSTEM STEERABLE GUIDE CATHETER VALVE REPAIR Back to Search Results
Catalog Number SGC0302
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
The customer reported the device was discarded. A follow-up report will be submitted with all additional relevant information. The mitraclip ntr referenced is filed under a separate medwatch report number.
 
Event Description
This is filed to report the steerable guide catheter soft tip tear. It was reported the mitraclip procedure was performed to treat degenerative mitral regurgitation (mr), with an mr grade of 4. The steerable guide catheter (sgc) and mitraclip delivery system (cds) were advanced. During the straddling step, the user did a check by moving the cds to confirm the distance of the atrium lateral wall. Grasping the leaflets was challenging and during grasping attempts the grippers arms stayed in the down position, independently of the gripper lever position. Additionally, the clip did not fully close further than 45 degrees. The clip was not implanted and the cds was retracted but got caught on the sgc soft tip. The sgc soft tip was damaged. Both devices were removed. Once the cds was outside of the anatomy, it was observed that the gripper arms did not look symmetric with the clip arms. When the clip was out, the physician closed the clip arm by hand, a "click" sound was heard and then the clip arm managed to be fully closed. At each sequence to open to close, the clip arm looked slightly blocked at 45 degree and managed to close finally. It cannot be determined if the clip damage occurred during movement of the cds during straddling or during removal of the cds. A new sgc was used and two clips were implanted without issue, reducing mr to 1-2. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameMITRACLIP SYSTEM STEERABLE GUIDE CATHETER
Type of DeviceVALVE REPAIR
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005070406
3885 bohannon drive
menlo park CA 94025
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11052703
MDR Text Key223137811
Report Number2024168-2020-10824
Device Sequence Number1
Product Code DRA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K161985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/04/2021
Device Catalogue NumberSGC0302
Device Lot Number00803U208
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/04/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/21/2020 Patient Sequence Number: 1
Treatment
MITRACLIP DELIVERY SYSTEM
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